Pone.0005699 1.7

Twelve Years’ Experience with Direct-to-ConsumerAdvertising of Prescription Drugs in Canada: ACautionary Tale
Barbara Mintzes1*, Steve Morgan2, James M. Wright3
1 Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, Canada, 2 School of Population and Public Health and
Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada, 3 Departments of Anesthesiology, Pharmacology and Therapeutics and
Medicine, University of British Columbia, Vancouver, Canada
Background: Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protectionmeasure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending onDTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares tothat in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public inreminder advertising.
Methodology/Principal Findings: Prescription drug advertising spending data were extracted from a data set on healthsector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflationand compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 millionper year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% ofspending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which hasa US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadiantelevision in 2005 and 2006. Of 8 brands with .$500,000 spending, which together accounted for 59% of branded DTCA inall media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings.
Conclusions/Significance: Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growthin television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidenceof safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. Forgovernments searching for compromise solutions to industry pressure for expanded advertising, Canada’s experiencestands as a stark warning.
Citation: Mintzes B, Morgan S, Wright JM (2009) Twelve Years’ Experience with Direct-to-Consumer Advertising of Prescription Drugs in Canada: A CautionaryTale. PLoS ONE 4(5): e5699. doi:10.1371/journal.pone.0005699
Editor: An-Wen Chan, Mayo Clinic, United States of America
Received January 8, 2009; Accepted April 30, 2009; Published May 27, 2009
Copyright: ß 2009 Mintzes et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permitsunrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: No specific funding - general University of British Columbia. The funders had no role in study design, data collection and analysis, decision to publish,or preparation of the manuscript.
Competing Interests: Dr. Mintzes has acted as a consultant for the Canadian government in a legal case on direct-to-consumer advertising (DTCA) in which amedia company, CanWest, is challenging the federal prohibition of DTCA.
* E-mail: Barbara Mintzes bmintzes@chspr.ubc.ca
The Canadian government has hosted several national
Similarly to all industrialized countries except the United States
consultations on DTCA and introduced two major shifts in
(US) and New Zealand, Canada prohibits direct-to-consumer
administrative policy. First, a 1996 Health Canada advertising
advertising (DTCA) of prescription drugs. However, Canada
policy statement [3] redefined the boundary between ‘information
differs from most other countries that prohibit DTCA in that there
dissemination’ and ‘advertising.’ The redefinition appears to have
is considerable population exposure to this advertising in US
provided tacit government approval for unbranded ‘disease-
media. Around 30% of English-speaking Canadians’ television
oriented’ advertisements [4]. These advertisements mention a
viewing is of US satellite and cable TV, which carries DTCA that
condition and suggest viewers or readers ‘ask your doctor’ about
available treatments but do not mention any brands [5].
Canada has experienced pressure for legislative change to
Second, in November 2000, Health Canada published an
introduce DTCA since the mid 1990’s. For example, Merck Frosst
administrative policy paper that allowed branded ‘reminder
argued in a 1996 submission to Health Canada that the industry
advertisements’ targeting the general public [6]. A reminder ad
had a legal right to advertise under freedom of expression
is a form of DTCA that states a brand name but does not mention
the product’s indication or make health claims. The November
2000 policy paper cited a 1975 regulatory amendment [7] (Food &
excluded from our analysis. We also excluded brands that are
Drugs Act, C.01.044) that was introduced to allow advertising of
available as both over-the-counter and prescription-only formula-
drug prices and, as described by Health Canada in 1984, thereby
‘‘to facilitate comparative shopping’’ [8].
Advertisements were classified as ‘unbranded prescription drug
Branded reminder ads rarely if ever state a product’s price.
advertising’ if the advertiser was a pharmaceutical company that
However, Health Canada judged reminder ads to be legal under
sells prescription-only drugs in Canada and no brand name was
the price advertising provision because advertising to the public of
mentioned. This includes both corporate image advertising and
‘name, price and quantity’ is allowed. This regulatory approach is
condition-related entries. An example of the latter type of entry is
unique: Canada is the only country that prohibits DTCA yet
‘acid reflux information’ with Astra Zeneca listed as the advertiser.
makes an exception for branded reminder advertising. Reminder
Annual spending for 1995 to 2005 was adjusted for inflation and
advertisements are prohibited in all other developed countries that
converted into year 2006 Canadian dollars using the within
ban DTCA. Moreover, although in general the US allows
country Consumer Price Index (all items). US figures were
prescription drug advertising to the public, the US FDA imposes
converted to Canadian dollars, using year-2006 Purchasing Power
restrictions on reminder advertising. These restrictions apply both
to ads targeting the public and professionals: no reminder ads are
We obtained a list of US drugs with black box warnings from a
allowed for drugs with a ‘black box’ warning — the strongest US
dedicated website, http://formularyproductions.com/blackbox/,
regulatory warning of serious harmful effects [5]. The US
email: , and checked the labels of all identified products on the US
restrictions apply both to products within a class with a boxed
FDA website’s search engine, drugs@fda, url: . Health Canada’s
warning extending to all members of the class (e.g. non-steroidal
safety advisories were obtained from an e-mail subscription service
anti-inflammatory drugs and the risk of gastro-intestinal bleeding),
(MedEffect e-Notice) and confirmed on Health Canada’s website:
and to product-specific warnings. The rationale for this prohibi-
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-
tion is public safety, as reminder advertising fails to provide
information on product risks. Canada does not impose analogouslimitations on reminder advertising, and also does not have a
system of ‘black box’ warnings. However, Health Canada sendsout safety advisories to the public and health professionals when
Figure 1 presents an overview of inflation-adjusted spending on
new evidence of product risks emerges post-approval.
branded advertising in outdoor, print and broadcast media. Totalinflation-adjusted spending on branded DTCA in Canada grew
from under $2 million per year prior to 1999 to over $22 million in2006. The major growth in spending in branded advertising has
There is no published research, beyond anecdotal reports, on
been in broadcast media, reaching 83% ($18.4 million) of
the experience with DTCA in Canada since the administrative
policy changes in 1996 and 2000. We therefore aimed to describe
Most of the spending on broadcast advertising has been on
annual spending on branded and unbranded advertising by
television ads ($15.5 million in 2006, or 84% of broadcast
prescription drug manufacturers in Canada from 1995 to 2006,
spending). There was no television DTCA from 1995 to 1997, and
and to compare spending over this period to US DTCA spending.
television represented only 5% of branded advertising spending in
This 12-year period was chosen to span Health Canada’s policy
1998 and 19% in 1999. However, branded television advertising
changes and, in particular, to provide a time period before and
became prominent from 2000 onwards, ranging from 34% to 70%
after the year 2000 policy shift regarding branded advertising.
of total branded advertising spending.
In addition to looking at overall levels and trends in spending on
From 1995 to 2006, the pharmaceutical industry spent $98.75
Canadian DTCA, we focused on heavily advertised products in
million on unbranded pharmaceutical advertising in Canada —
terms of conditions treated and whether or not these products had
see Table 1. From 1995 to 2000, spending on unbranded ads in
been subject to regulatory warnings of serious risks, including US
Canada was three or more times the spending on brand-specific
‘black box’ warnings or Health Canada safety advisories.
ads. From 2002 onwards, annual spending on branded reminderads in Canada was consistently higher than on unbranded ads.
A total of CAD$191.23 million was spent on branded and
We obtained data from a market research company, TNS
unbranded DTCA in Canada between 1995 and 2006. Over the
Media Inc., which tracks advertising spending in the US and
same period, CAD$36.19 billion was spent on DTCA in the US.
internationally. Data were obtained covering all health sector
Even on a per capita basis, DTCA spending in Canada was much
spending in Canada on television, radio, magazines, newspapers
lower than in the US during the entire time period. However, in
and outdoor billboards for a 12-year period, from 1995 to 2006
relative terms DTCA spending in Canada has grown more rapidly
(n = 12,372 entries) Data were also obtained from TNS Media on
since 2001 than DTCA spending in the US. Spending in 2006 was
US DTCA spending, with all media combined, from 1997 to
over double the amount spent in 2001; whereas US spending
2005. We used published US data on DTCA spending for 1995
increased by 66% over the same time period.
[9] and 1996 [10] and IMS Health data for 2006 [11]. These three
DTCA spending in Canada is highly concentrated on relatively
sources all report on data obtained from TNS Media or
few products, particularly early in the period being analyzed. Only
Competitive Media Reporting (a company that was bought by
one product per year was advertised in 1995 and 1996; this grew
TNS Media in 2000). The US data cover all types of DTCA: full
to 7 products in 1999, 13 in 2003 and 20 in 2006. In total, 48
product advertising (with both brand names and health claims),
brands were advertised to the public over the 12-year period.
reminder advertising, and unbranded ‘help-seeking’ ads.
Spending on prescription drug advertising was extracted
manually by product and manufacturer name. All brand names
were checked against Health Canada’s Drug Product Database so
Table 2 lists the top 15 products by advertising spending from
that vaccines, over-the-counter drugs and medical devices could be
2001 to 2006, representing 99% of spending within this time
Figure 1. Inflation-adjusted spending on branded direct-to-consumer advertising, 1995 to 2006 (year-2006, CAD$ millions).doi:10.1371/journal.pone.0005699.g001
Table 1. Inflation-adjusted spending on DTCA in the U.S. and Canada, all media, 1995 to 2006 (CAD$ millions)*.
CAD# DTCA CAD spending CAD spending
CAD = Canada; USA = United States.*inflation-adjusted spending expressed in equivalent of year-2006 dollars.{includes both unbranded disease-oriented advertising and corporate image advertisements.**US data converted to CAD$, using year-2006 Purchasing Power Parity (general GDP PPP).References, US data: 1995: Rosenthal et al. 2002 [8], calculated from Figure 1; 1996: Donohue et al. 2007 [9]; 2006: IMS Health. Total US promotional spend by type, 2007.www.imshealth.com/deployedfiles/imshealth/Global/Content/StaticFile/Top_Line_Data/PromotionalSpendChartWebsite.pdf.All other Canadian and US data from TNS Media Inc.doi:10.1371/journal.pone.0005699.t001
period, and 95% of spending from 1995 to 2006. Viagra
estradiol), which is not approved in the US, has been subject to
(sildenafil) tops the list and is responsible for 26% of spending
two safety advisories in Canada [13,14]. It is indicated in Canada
as a second line treatment for severe acne in women.
These advertised products are also concentrated within
relatively few indications: 9 of the 15 are contraceptives,
impotence or acne treatments. Pfizer is responsible for 44% ofspending, on three products, from 2001 to 2006. In 2006,
Although Canada’s Food & Drugs Act clearly states that
Celebrex (celecoxib) was the most heavily advertised medicine
advertising of prescription-only drugs to the public is prohibited,
the pharmaceutical industry has spent over CAD $90 million onbranded advertising in Canada from 1995 to 2006. Almost all(88%) of this spending on branded advertising occurred after
Health Canada stated in 2000 that branded reminder advertising
Table 3 lists all of the medicines advertised on television during
was consistent with a regulatory amendment created to encourage
2005 and 2006. Advertising was concentrated on eight brands for
price competition in the 1970s. This interpretation in effect
which advertising spending exceeded CAD$500,000 during either
created a regulatory loophole allowing reminder advertising to
2005, 2006, or both of these years. In contrast, spending on each
of the remaining 11 ‘minimally advertised’ brands was less than
The growth in advertising spending since the year 2000 strongly
suggests that policy decisions regarding Canada’s regulatory
Seven of the eight brands heavily advertised on television in
provisions matter. Advertisers may not have been as willing to
Canada during 2005 or 2006 are approved for sale in both
spend the large sums required to produce broadcast (particularly
countries, and four (57%) have US black box warnings. Together
television) ads if Health Canada’s policy statements had not
these eight brands represent 99.7% of television advertising and
provided some assurance that government would allow branded
59.2% of total branded DTCA spending over these two years. In
three cases, the warnings are for risks shared by the entire drug
The safety profile of the products that have been heavily
class: cardiovascular risks associated with use of estrogen-
advertised raises a further note of caution. Many of the drugs
containing contraceptives in women who smoke and are over 35.
featured in reminder advertising have been subject to Canadiansafety advisories and to US ‘black box’ warnings.
The most heavily advertised product in Canada during 2006
In total, five of the eight heavily advertised products in 2005 and
was Celebrex (celecoxib). Celecoxib is a cox-2 selective inhibitor.
2006 were subject to Health Canada safety advisories, excluding a
Similarly to rofecoxib, celecoxib is associated with increased
warning about counterfeiting of atorvastatin (Lipitor). In addition
cardiovascular risks in a dose-related manner [15]. Health Canada
to celecoxib and the contraceptive patch, Health Canada also sent
issued its first safety advisory on celecoxib in 2002 [16], warning
out a joint warning of visual adverse effects for three erectile
physicians of similar risks of gastrointestinal bleeding to other non-
dysfunction drugs in the same class: sildenafil, vardenafil and
steroidal anti-inflammatory drugs. A 2004 advisory focused on
tadalifil [12]. Another product, Diane-35 (cyproterone and
cardiovascular risks [17], and in 2005, Health Canada warned
Table 2. Top 15 brands by advertising spending, all media, 2001–2006.
LNG = levonorgestrel; EE = ethinylestradiol.*Bayer acquired Berlex in 2007.doi:10.1371/journal.pone.0005699.t002
Table 3. Safety advisories and black box warnings: products advertised on television, 2005 and 2006.
Tri Cyclen Lo / Tri Cyclen (norgestimate/EE)
Minimally advertised (annual spending ,$30,000)
Packaging problem, mixed with another -product (2005)
physicians not to prescribe this drug to patients with heart disease
failed to prevent advertising of products with a serious potential
and recommended restricting prescriptions to : ‘‘… the lowest
possible dose, and for the shortest, necessary period of time’’ [18].
The US industry association, PhRMA, announced self-regula-
The heaviest advertising spending in Canada on celecoxib was in
tory guidelines in July 2005, prohibiting television reminder
2006, after this advisory. Celecoxib was also advertised to the US
advertising [22]. Coming six months after rofecoxib’s withdrawal,
these guidelines have been interpreted as a response to the safety
In 2005, Janssen-Ortho spent CAD $2.1 million advertising the
concerns raised about the effects of DTCA following rofecoxib’s
contraceptive patch Evra (norelgestromin/ethinyl estradiol) to the
withdrawal [23]. There are no published evaluations of the impact
Canadian public. Evra’s US black box warning is a class warning
of these guidelines in the US. In Canada, spending on televised
for all estrogen-containing contraceptives, but the patch has also
reminder ads increased in 2006. All of the manufacturers with
been found to have a higher dose of estrogen than expected,
spending over $500,000 are Canadian subsidiaries of PhRMA
leading to increased risks of venous thromboembolism. The FDA
members or, in one case, the Canadian subsidiary of a European
has sent out an advisory and required a labeling change as a result
company with a US subsidiary that is a PhRMA member.
[19]. Excess risks of venous thromboembolism also spurred Health
Despite the rise in spending in Canada during recent years, the
Canada to send out two safety advisories warning physicians not to
volume of advertising pales in comparison with the US. US
prescribe Diane-35 (cyproterone/ethinyl estradiol) for contracep-
advertisers spent on average 24 times the amount spent per capita
tion or mild acne [13,14]. Although this product is only approved
in Canada: a total of CAD $36.187 billion from 1995 to 2006.
as a second-line treatment for severe acne, it has been widely
Additionally, although per capita spending is increasing in
prescribed for unapproved uses: 45.5% of women in British
Canada, annual growth is much lower in absolute terms than in
Columbia who obtained initial prescriptions from1998 to 2003
the US: on average CAD $0.12 per year from 2001 to 2006, versus
had no evidence of acne diagnosis or treatment within the previous
CAD $1.53 in the US. Thus if current trends in both countries
year [20]. Health Canada judged advertisements for Diane-35 to
continue unchanged, exposure levels would be expected to remain
be illegal, but found it difficult to prevent repeat violations [8].
These examples highlight the disconnect between marketing
In the US, full product ads are the most common form of
decisions to run DTCA campaigns aiming to stimulate sales and
televised DTCA [24,25]. Because of their extra length, they are
regulatory warnings attempting to limit use. Topol faulted the
more expensive than reminder ads. If companies choose this form
US FDA for allowing intensive DTCA for Vioxx (rofecoxib)
of advertising for brands that can be legally advertised through
despite mounting evidence of cardiovascular toxicity [21]. Our
reminder ads, it is likely because of a stronger observed effect on
analysis indicates, similarly, that regulators in Canada have
Donohue and colleagues reviewed the experience with US
in response to differences in provincial formulary listings for some
DTCA from 1996 to 2005 [10]. In addition to the higher spending
advertised drugs. Additionally, as all publicly reported US data on
levels, a much broader range of products has been advertised to
DTCA spending derive from TNS Media, we could not check
the public in the US than in Canada over this period. The drug
accuracy against another source. It was not always possible to
classes with over 30% of promotional spending dedicated to
distinguish corporate image advertisements from unbranded
DTCA included statins, proton pump inhibitors and erythropoi-
‘disease-oriented’ ads; spending on unbranded DTCA is therefore
etin products. The latter are used to avoid the need for
likely to be an overestimate. Additionally, although the US
transfusions in cancer patients undergoing chemotherapy. A US
restricts reminder advertising of drugs with black box warnings on
Congressional hearing critiqued unsubstantiated claims of reduced
public health grounds, there has been no evaluation of the health
fatigue and improved quality of life in DTCA promoting these
agents for chemotherapy patients [26]. The US FDA issued ablack box warning for the class in 2007 of increased mortality,
serious cardiovascular and thromboembolic risks, and tumour
This review of 12 years of advertising spending in Canada is a
progression or recurrence, particularly when used in patients with
sobering reality check: many of the most heavily advertised
haemoglobin levels over 12 g/dL [27]. The experience with
products have been subject to regulatory warnings of serious risks.
erythropoietin illustrates a key concern about the effects of DTCA
If public health is to be taken seriously, Canada’s government
on public safety. Many prescription medicines are potentially
needs to take action to stop reminder advertising. It makes no
hazardous and must be used judiciously in order to ensure that for
sense to send out safety advisories telling physicians to prescribe a
a specific patient, the potential for benefit outweighs the
drug cautiously because of serious risks and then, using a
probability of harm. This need for limited use is at odds with
regulatory loophole created to foster price competition, to turn a
advertisers’ imperative to stimulate expanded sales.
blind eye to persuasive advertisements that make the same drug
Despite the legal requirement for risk information in US full
look like an effortless key to happiness and good health. The
product advertising, provision is often inadequate. Minimization
suggestion to ‘ask your doctor’ is no guarantee that the viewer is
or omission of risks is the most frequent US regulatory violation,
protected, as doctors often prescribe medicines that patients
repeat violations are common, and as DTCA volume hasincreased over time, the proportion of ads the FDA is able to
request although they might not have otherwise chosen to do so
There is also evidence of poor communication of harmful effects
In 2003 and early 2004, Canada’s parliamentary health
in advertising that meets regulatory requirements. Adults with low
committee held hearings across the country on pharmaceutical
literacy who were tested for comprehension of information in
policy, including DTCA. The committee highlighted the problem
television ads scored much lower on risks than benefits [29]. In a
of reminder advertising, stating that: ‘‘any direct-to-consumer
systematic sample of magazine ads for HIV/AIDS drugs, 55% of
advertising, including reminder ads, could contribute to increased or
drugs with black box warnings or life-threatening harmful effects
inappropriate drug consumption’’ [34]. Since this committee’s investi-
provided incomplete information on these risks, and 48% failed to
gation, spending on DTCA in Canada has more than doubled.
highlight them graphically [30]. Content analyses of systematic
The US experience of widespread harm associated with the use of
samples of DTCA have found that most ads fail to provide the
the heavily advertised arthritis drug Vioxx (rofecoxib) [35] has also
information needed for shared informed treatment choice [31],
led to proposals for restrictions on DTCA as public safety
benefits are described in vague, emotive terms [32] and emotional
measures, such as the Institute of Medicine’s recommendation for
appeals such as happiness, control over one’s life and social
a 2-year moratorium on advertising of new drugs [36].
The experience in Canada provides a cautionary tale for
In sum, the US experience illustrates why allowing full product
governments in the European Union and elsewhere who are
advertising is not a solution to Canada’s problem of reminder
attempting to juggle industry demands for greater ability to
advertising for drugs with serious risks. Neither the inadequate
‘inform’ the public about their medicines with public, professional
communication of risks nor the negative consequences of
and parliamentary reluctance to introduce ‘US-style’ prescription
stimulating use of products with a serious potential for harm
would be resolved. From a public health perspective, a betterapproach would be to address the problem directly, by closing the
regulatory loophole that has allowed this advertising to flourish.
This study has several limitations. Our results are purely
We would like to thank Stephen Adams and Jennifer Evans for theirassistance with data extraction.
descriptive. Advertising spending is only a rough proxy forpopulation exposure, and the relationship between spending andexposure varies over time and by media type. We report only on
total Canadian spending and could not examine whether
Conceived and designed the experiments: BM JMW. Analyzed the data:
advertising intensity differed by province, as might have occurred
1. Law M, Majumdar SR, Soumerai SB (2008) Effect of illicit direct to consumer
and Food Branch, Health Canada. Available: http://www.hc-sc.gc.ca/
advertising on use of etanercept, mometasone, and tegaserod in Canada. BMJ
dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php via the Internet.
2. Merck Frosst (1996) Direct-to-Consumer Advertising of Prescription Pharma-
4. Gardner DM, Mintzes B, Ostry A (2003) Direct-to-consumer prescription
ceuticals. A Merck Frosst Position Paper on How to Use Comprehensive Patient
drug advertising in Canada: Permission by default? CMAJ 169: 425–
Information to Deliver Improved, Cost-Effective Health Outcomes. Submission
to Health Canada Consultation on Direct-to-Consumer Advertising of
5. Woodcock J (2003) Director, Center for Drug Evaluation and Research. US
Prescription Drugs. Ottawa: June 17, 1996.
Food and Drug Administration. FDA Regulates prescription drug promotion.
3. Nichols DM (2005 Aug) The Distinction Between Advertising and Other
Testimony before the Senate Special Committee on Aging. July 22, 2003.
Activities. Administrative update of January 12, 1996 policy. Health Products
Washington DC. Accessed November 17, 2008. Available: http://www.fda.gov/
ola/2003/AdvertisingofPrescriptionDrugs0722.html via the Internet. Accessed
22. PhRMA (2005) Guiding Principles. Direct-to-consumer advertisements about
prescription medicines. August 2005. Available: http://www.phrma.org/files/
6. Rowsell LB (2000) Advertising Campaigns of Branded and Unbranded Messages. Policy
DTCGuidingprinciples.pdf via the Internet. Accessed 04 May 2009.
statement. Therapeutic Products Directorate, Health Canada, November 2000.
23. Anon (2005) FDA, PhRMA set to make major DTC announcements. Medical
7. Canada’s Food and Drugs Act and Regulations. Available: www.hc-sc.gc.ca/food-
Marketing & Media. August 2, 2005.
aliment/friia-raaii/food_drugsaliments_drogues/act-loi/e_index.html via the Inter-
24. Frosch DL, Krueger PM, Hornik RC, Cronholm PF, Barg FK (2007) Creating
Demand for Prescription Drugs: A Content Analysis of Television Direct-to-
8. Sztuke-Fournier A (2006) Ontario Superior Court of Justice. Between CanWest
Consumer Advertising. Ann Fam Med 5: 6–13.
MediaWorks Inc. and Attorney General of Canada. Affidavit of Ann Sztuke-
25. Brownfield ED, Bernhardt JM, Phan JL, Williams MV, Parker RM (2004)
Fournier. 05-CV-303001PD2. June 2006. Available: http://www.whp-apsf.ca/
Direct-to-Consumer Drug Advertisements on Network Television: An Explora-
en/documents/charter.html via the Internet. Accessed 04 May 2009.
tion of Quantity, Frequency, and Placement. Journal of Health Communication
9. Rosenthal MB, Berndt ER, Donohue JM, Epstein AM, Frank RG (2002)
Promotion of prescription drugs to consumers. N Engl J Med 346: 498–505.
26. Stupak B (2008) ‘‘Direct-to-consumer advertising. Marketing, education or
10. Donohue JM, Cevasco M, Rosenthal MB (2007) A decade of direct-to-consumer
deception?’’ Chairman’s Opening Statement. Subcommmittee on oversight and
advertising of prescription drugs. N Engl J Med 357: 673–81.
investigations. House Committee on Energy and Commerce, US Congress.
11. IMS Health (2008) Total US Promotional Spend by Type, 2007. Available:
Washington DC: May 8, 2008. Available: http://energycommerce.house.gov/
www.imshealth.com/deployedfiles/imshealth/Global/Content/StaticFile/To-
Subcommittees/OI-Stupak/050808.OI.hrg.DTC.pdf. Accessed March 23,
p_Line_Data/PromotionalSpendChartWebsite.pdf via the Internet. Accessed 03
27. FDA Alert (2007) Information for healthcare professionals: erythropoiesis
12. Health Canada. Health Canada advises about vision problems possibly
stimulating agents (ESA) [Aranesp (darbepoetin), Epogen (epoetin alfa), and
associated with Viagra, Cialis and Levitra. Advisory. July 26, 2005. Available:
Procrit (epoetin alfa)]. Rockville, MD: Food and Drug Administation, March 9,
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2005/2005_83-eng.
2007. Available: http://www.fda.gov/cder/drug/InfoSheets/HCP/
php via the Internet. Accessed 03 March 2009.
RHE2007HCP.htm via the Internet. Accessed 03 March 2009.
13. Marketed Health Products Directorate, Health Canada (2002) Important Safety
28. US Government Accountability Office (2006) Prescription drugs: improvements
Concerns on the Use of Diane-35. December 19, 2002. Available: http://www.
needed in FDA’s oversight of direct-to-consumer advertising. Washington DC.
hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2002/diane-35_hpc-cps-
GAO-07-54. November 2006. Available: www.gao.gov/cgi-bin/getrpt?GAO-
eng.php via the Internet. Accessed 03 March 2009.
07-54 via the Internet. Accessed 03 March 2009.
14. Health Canada (2003) Public Advisory: Diane-35 and the risk of venous
29. Kaphingst KA, Rudd RE, Dejong W, Daltroy NL (2005) Comprehension of
thromboembolism. Berlex Canada Inc. Consumer Information. Available:
information in three direct-to-consumer television prescription drug advertise-
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2003/diane-
ments among adults with limited literacy. Journal of Health Communication 10:
35_pa-ap-eng.php via the Internet. Accessed 03 March 2009.
15. Cotter J, Wooltorton E (2005) New restrictions on celecoxib (Celebrex) use and
30. Kallen A, Woloshin S, Shu J, Julh E, Schwartz L (2007) Direct-to-consumer
the withdrawal of valdecoxib (Bextra). CMAJ 172(10): 1299.
advertisements for HIV antiretroviral medications: a progress report. Health
16. Health Canada (2002) Important safety information for patients taking
Celebrex. Advisory May 23, 2002. Ottawa. Available: http://www.hc-sc.gc.
ca/ahc-asc/media/advisories-avis/_2002/2002_40-eng.php via the Internet.
31. Bell RA, Wilkes MS, Kravitz RL (2000) The educational value of consumer-
targeted prescription drug print advertising. J Fam Pract 49(12): 1092–1098.
17. Health Canada (2004) Updated safety information on increased cardiovascular
32. Woloshin S, Schwartz LM, Tremmel J, Welch HG (2001) Direct-to-consumer
risk with Celebrex (celecoxib). December 17, 2004. Ottawa. Available: http://
advertisements for prescription drugs: What are Americans being sold? Lancet
www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2004/2004_67-eng.php via
the Internet. Accessed 03 March 2009.
33. Mintzes B, Barer ML, Kravitz RL, Bassett K, Lexchin J, et al. (2003) How does
18. Health Canada (2005) Health Canada has asked Pfizer to suspend sales of its
direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary
drug BextraTM and informs Canadians of new restrictions on the use of
care environments with and without legal DTCA. CMAJ 169: 405–412.
Celebrex. April 7, 2005. Available: http://www.hc-sc.gc.ca/ahc-asc/media/
34. Standing Committee on Health (2004 April) Opening the Medicine Cabinet:
advisories-avis/_2005/2005_17-eng.php via the Internet. Accessed 03 March
First Report on Health Aspects of Prescription Drugs. Ottawa: House of
Commons. Available: www.parl.gc.ca/InfocomDoc/Documents/37/3/parl-
19. US Food and Drug Administration (2005) FDA Updates Labeling for Ortho
bus/commbus/house/reports/healrp01/healrp01-e.pdf via the Internet. Ac-
Evra Contraceptive Patch. November 2005. Available: http://www.fda.gov/
bbs/topics/news/2005/NEW01262.html via the Internet. Accessed 03 March
35. Graham DJ, Campen D, Hui R, Spence M, Cheetham C, et al. (2005) Risk of
acute myocardial infarction and sudden cardiac death in patients treated with
20. Mintzes B, Morgan S, Bassett KL (2005) Medicine by media: did a critical
cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory
television documentary affect prescribing of cyproterone – estradiol (Diane 35).
drugs: Nested case-control study. Lancet 365(9458): 475–481.
36. Institute of Medicine of the National Academies (2006) The future of drug safety:
21. Topol EJ (2004) Failing the Public Health — Rofecoxib, Merck, and the FDA.
promoting and protecting the health of the public. Available: http://fermat.nap.
edu/books/0309103045/html/15.html via the Internet. Accessed Nov 9 2006.